Continuum Labs LGD-4033 by Invisiblu International: Recall - Investigational Drug Not Approved for Use

[Posted 04/05/2016]

AUDIENCE: Consumer

ISSUE: Invisiblu International LLC is voluntarily recalling one lot of Continuum Labs LGD-Xtreme, 3 mg to the retail and consumer level. The product has been found to contain LGD-4033 Ligandrol, an investigational drug not approved for use. The risks of using this product are unknown.

The affected LGD-Xtreme lot numbers are 21511166 with expiration dates of 11/2018.

BACKGROUND: LGD-Xtreme is marketed as a dietary supplement to promote gains of lean muscle mass. The product is packaged in a dark amber plastic bottle with ninety capsules. The product can be identified by its black label with gold trim and the Continuum Labs logo. LGD-Xtreme was sold to select end consumers in the United States via the Internet, and was exported to wholesalers in Brazil. See the Press Release for product photos.

RECOMMENDATION: Invisiblu International LLC is asking anyone in possession of this product to stop using and discard any unused capsules.

Consumers with questions regarding this recall can contact Invisiblu International LLC by calling (954) 233-2673, extension 1, Monday through Friday, from 9 AM to 5 PM EDT, or by sending an e-mail to: inquiry@continuum.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/05/2016 - Press Release - Invisiblu International LLC]